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Completed
NCT04798014
HERO-2: Home-Reported Outcomes With CFTR Modulator Therapy
Conditions: Cystic Fibrosis
Sex: All
Ages: 12 Years – N/A
Healthy volunteers: No
Enrollment: 860
Sponsor: Indiana University
Location: Indiana University School of Medicine Indianapolis Indiana
Summary
This is an observational cohort study, using data from Folia Health and the Cystic Fibrosis Foundation Patient Registry (CFFPR). Individuals taking elexacaftor/tezacaftor/ivacaftor (ETI) may be enrolled through the Folia application. During the 12-month study period, participants will be asked to track their routine treatment and medication usage, daily symptoms, and monthly review with validated patient-reported outcome (PRO) questionnaires. Participants will also be asked to self-report instances of changes to their treatment plan, and pulmonary exacerbations. There are no study-associated site visits.
Eligibility Criteria
Inclusion Criteria:
* Written informed consent (and assent when applicable) obtained from subject or subject's legal guardian.
* Is willing and able to adhere to protocol requirements.
* ≥ 12 years of age at enrollment.
* Diagnosed with CF.
* Prescribed ETI for an on-label indication.
* Participant has access to a mobile phone or tablet (iPhone or Android platform) or computer.
* Participant has access to an internet connection.
Exclusion Criteria:
* Participant is enrolled in the randomized portion of the SIMPLIFY study (NCT04378153).
* Participant does not have access to the necessary technology.
* Participant is a recipient of a solid organ transplant (i.e. lung, liver, pancreas, kidney).
* Participant cannot communicate in English.
Source: ClinicalTrials.gov (NCT04798014). StuddyBuddy aggregates publicly available trial information.